BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis

Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal
Release Tablets) for Acute Gastroenteritis.

The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute
Gastroenteritis, by comparing it to placebo.

Inclusion Criteria:

- Patients must have vomited at least twice in the 4 hours preceding signing informed
consent. A vomiting episode is defined as an episode of forceful expulsion of stomach
contents. Retching if a patient has already emptied his or her gastric contents is
also considered vomiting episode. A distinct episode is characterized by a clear break
in vomiting activity of at least 5 minutes

- Emesis must have been nonbloody (streaks of blood presumed due to force of retching
are allowed)

- All patients (and a parent or guardian for patients consent.

Exclusion Criteria:

- Severe dehydration. Severe dehydration is defined as two or more of the following
criteria in the presence of decreased intake and increased output due to vomiting or
diarrhea: Absent or severely decreased urine output; weak pulse and/or low blood
pressure; parched mucous membranes; lethargy, confusion, delirium or loss of
consciousness

- Signs and symptoms severe enough to require immediate parenteral hydration and/or
parenteral antiemetic medication

- Temperature>39.0

- Likely etiologies for acute vomiting and diarrhea other than acute infectious or toxic
gastroenteritis or gastritis. This includes signs of an acute abdomen, which may
require surgical intervention

- Chemically-induced gastroenteritis, e.g., from alcohol, other drugs of abuse or other
irritant chemicals

- Use within 24 hours of study entry of specific medication for treatment of nausea
and/or vomiting, e.g., 5-HT3 antagonists or phenothiazines, or receipt of any IV fluid
for any reason. Nonspecific gastrointestinal remedies, such as antacids, proton pump
inhibitors and homeopathic remedies, are permitted.

- Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QT
syndrome

- Patient who have known QTc prolongation > 450 msec, noted on prior or screening ECG,
or who are taking medication known to cause QT prolongation. Note: for current list of
medications known to cause QT prolongation see:
https://www.crediblemeds.org/healthcare-providers/drug-list/ Use list showing drugs
with known risk TdP.

- Known underlying disease which could affect assessment of hydration or modify outcome
of treatment, e.g., renal failure, diabetes mellitus, liver disease, alcoholism.
Patients with type 2 diet-controlled diabetes mellitus whose baseline blood glucose is
<200 may be entered into the study

- Abdominal surgery within the past 3 months

- History of bariatric surgery or bowel obstruction at any time

- Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists

- Patient has taken apomorphine within 24 hours of screening

- Patient has previously participated in this study

- Patient has participated in another interventional clinical trial, for any indication,
in the past 30 days

- For women of childbearing potential: documented or possible pregnancy.